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Trial registered on ANZCTR


Registration number
ACTRN12616001094460
Ethics application status
Approved
Date submitted
12/07/2016
Date registered
12/08/2016
Date last updated
12/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of faecal transplant on insulin sensitivity in adults with pre-diabetes and diet-controlled diabetes
Scientific title
The potential impact of faecal microbial transplant on insulin sensitivity in adults with pre-diabetes and diet-controlled diabetes
Secondary ID [1] 289656 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 299456 0
Condition category
Condition code
Metabolic and Endocrine 299435 299435 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group of overweight adults with pre-diabetes or diet-controlled diabetes will be randomised to receive a faecal microbial transplant (FMT) from either a lean healthy donor or their own gut microbiota. The donated faeces will be homogenised with 500 mL of normal saline in a blender and all of the 500 mL will be infused via colonoscopy into the colon of the recipient. The colonoscopy will take approximately 20 minutes and will be performed by a gastroenterologist. Measurements of weight, HbA1c, fasting glucose and insulin, and oral glucose tolerance test will be performed at regular intervals post-FMT to determine effect of gut microbiota transfer on weight and glucose metabolism. No specific strategies to monitor adherence are required.
Intervention code [1] 295282 0
Prevention
Comparator / control treatment
The control group will be made up of overweight adults with pre-diabetes or diet-controlled diabetes receiving their own gut microbiota.
Control group
Active

Outcomes
Primary outcome [1] 298906 0
Primary outcome will be insulin sensitivity assessed by homeostatic model assessment (HOMA-IS) and oral glucose tolerance test-based insulin sensitivity (OGIS).
Timepoint [1] 298906 0
Post-FMT days 3, 7, 14, 21, 28
Post-FMT weeks 6, 8, 12
Secondary outcome [1] 325627 0
Body weight by digital scales
Timepoint [1] 325627 0
Post-FMT days 3, 7, 14, 21, 28
Post-FMT weeks 6, 8, 12
Secondary outcome [2] 326059 0
Fasting glucose by serum assay
Timepoint [2] 326059 0
Post-FMT days 3, 7, 14, 21, 28
Post-FMT weeks 6, 8, 12
Secondary outcome [3] 326060 0
Oral glucose tolerance test by serum assay
Timepoint [3] 326060 0
Post-FMT weeks 6 and 12
Secondary outcome [4] 326061 0
HbA1c by serum assay
Timepoint [4] 326061 0
Post-FMT week 12

Eligibility
Key inclusion criteria
Eligibility criteria will be:
Body mass index (BMI) of 25 kg/m2 or greater.
Aged 18 years or above.
Fasting blood glucose >6.0 mmol/L or HbA1c >40 mmol/mol
Not taking any glucose lowering medications
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anyone lacking mental capacity to provide informed consent.
Prebiotic/probiotic supplements or antibiotics in the last 3 months.
Past cholecystectomy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be by central randomisation via phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, the sample size is small and partly determined by what is felt to be an achievable number to recruit over the study period. Feasibility of recruitment will be assessed during the study.
We will analyse the results using a mixed models approach, which takes into account repeated measurements in individuals and allows comparison at different time points using Tukey post-hoc tests. Statistical analyses will be performed using the most recent version of SPSS software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 8024 0
New Zealand
State/province [1] 8024 0
Auckland

Funding & Sponsors
Funding source category [1] 294040 0
Charities/Societies/Foundations
Name [1] 294040 0
New Zealand Society for the Study of Diabetes
Country [1] 294040 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292861 0
None
Name [1] 292861 0
Address [1] 292861 0
Country [1] 292861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295456 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 295456 0
Ministry of Health
Ethics Department
Freyberg Buidling
Reception – Ground Floor
20 Aitken St
Wellington 6011
NEW ZEALAND
Ethics committee country [1] 295456 0
New Zealand
Date submitted for ethics approval [1] 295456 0
09/10/2015
Approval date [1] 295456 0
14/01/2016
Ethics approval number [1] 295456 0
15NTB197

Summary
Brief summary
There is growing evidence that gut microbiota is involved in the pathogenesis of type 2 diabetes mellitus. In humans, there is very little data on the effect of gut microbiota transfer on glucose metabolism. The objective of this study is to examine the feasibility of performing colonic faecal microbiota transplantation (FMT) in overweight pre-diabetic/diabetic adults and any potential metabolic effects of altering human colonic microbiota on insulin sensitivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67354 0
Dr Maggie Ow
Address 67354 0
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 67354 0
New Zealand
Phone 67354 0
+6421424956
Fax 67354 0
Email 67354 0
[email protected]
Contact person for public queries
Name 67355 0
Maggie Ow
Address 67355 0
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 67355 0
New Zealand
Phone 67355 0
+6421424956
Fax 67355 0
Email 67355 0
[email protected]
Contact person for scientific queries
Name 67356 0
Maggie Ow
Address 67356 0
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 67356 0
New Zealand
Phone 67356 0
+6421424956
Fax 67356 0
Email 67356 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.